Intravenous catheter apparatus



Nov. 2, 1965 F. w. PODHORA 3,215,141

INTRAVENOUS CATHETER APPARATUS Filed Feb. 4, 1963 FRED D. PODHORAlNVE/VTOR.

BUG/(HORN, BLORE, KLAROU/ST 8 SPAR/(MAN ATTORNEYS United States Patent3,215 141 INTRAVENOUS CATI IETER APPARATUS Fred W. Podhora, 7429 SW.59th Ave., Portland, Oreg. Filed Feb. 4, 1963, Ser. No. 255,741 4Claims. (Cl. 128214) The present invention relates to apparatus forintravenous introduction of a fluid in a patient and more particularlyto apparatus for introducing a catheter into vein of a patient for usein intravenous introduction of fluid to such vein.

As it is now well known, an injection or an infusion of liquids such asblood, saline solutions, and other materials into a vein of a patient isin many cases extremely helpful and, in fact, sometimes necessary to thesuccessful recovery of the patient. Until recently the injection orinfusion was accomplished by inserting a hollow needle having arelatively large lumen into the vein or other portion of the body intowhich liquid was to be infused or injected and connecting a liquidconduit to the needle so as to effect the infusion of the liquid intothe vein through the needle. A use of a needle in this manner is notdesirable in several aspects. First the arm or portion of the body inwhich the needle is inserted must be immobilized during the period oftransfusion or infusion to make certain that no relative movementbetween the needle and the patients body occurs since the sharp edges ofthe needle might cause trauma to the vessel walls, or the puncture ofthe vessel wall and unnecessarily injure the patient. Furthermore, itmay be necessary to make periodic infusions over a long period of timeand the presence of the needle, if left in the body, is irritating tothe patient and, of course, creates a possibility of injury if leftwithin the patients arm. Accordingly, attempts recently have been madeto develop techniques wherein a catheter of plastic or similar materialis inserted through a vein puncturing needle into the vessel into whichthe infusion is to be made and the needle removed from the opening andimmobilized at some remote position leaving the catheter in place.

It is an object of the present invention to provide new and improvedapparatus of the latter type.

More particularly, it is an object of the present invention to provide anew and improved apparatus for introducing a catheter into a vein inwhich the needle can be immobilized with greater assurance that noinjury will occur to the patient.

Still another object of the invention is to provide a catheter apparatusof the class described in which the catheter is of improvedconfiguration so as to minimize possible trauma to the vessel wallduring the insertion of the catheter in a body vessel.

A further object of the invention is to provide an infusion apparatus tothe type described which can be manipulated easily to insert thecatheter into the vessel of a patient and which does not require the useof sterile gloves or hand scrubbing by the operator prior to the use ofthe device.

Still another object of the invention is to provide apparatus of theclass described which is of simplified construction and which may bemanufactured easily at a relatively low cost.

Still another object of the invention is to provide a catheter apparatuswhich will minimize any possibility of air embolism upon the attachmentof an infusion apparatus to the catheter and the start of an injectionof fluid into a patient.

Still other objects and advantages of the invention will become moreapparent hereinafter.

For more detailed description of the invention reference is made to thefollowing drawings wherein:

FIG. 1 is a longitudinal sectional view of apparatus made in accordancewith the invention;

3,215,141 Patented Nov. 2, 1965 FIG. 2 is an enlarged cross-sectionalview taken along line 2-2 of FIG. 1;

FIG. 3 is an enlarged fragmentary view of the end of a catheter made inaccordance with the invention;

FIG. 4 is an enlarged sectional view of a portion of the apparatus ofthe invention;

FIG. 5 is another view of the apparatus shown in FIG. 4 showing it inanother condition of operation;

FIG. 6 is a sectional view taken along line 66 of FIG. 4;

FIG. 7 is an enlarged sectional view taken along line 77 of FIG. 1;

FIG. 8 is a fragmentary perspective view showing the operation of theapparatus in making a venipuncture;

FIG. 9 is a perspective view showing the manner of use of the apparatusin making an infusion; and

FIG. 10 is a fragmentary perspective view, partly in section, of theapparatus of the invention showing a step in the preparation of theapparatus for making an infusion.

Referring now to the drawings and more particularly to FIG. 1, theapparatus of the invention includes an elongate hollow needle 20 ofuniform inner and outer diameter throughout its length, the needlehaving a proximal end 22 provided with a sharpened edge for making avenipuncture. The distal end of the needle 20 is slipfitted into acounterbore 24 formed in the proximal end of a tubular needle holder 26which is preferably formed of a semirigid plastic material such asmolded polyethylene or vinyl. The counterbore 24 defines a shoulder 28against which the distal end of the needle 20 engages. The distal end ofthe needle holder 26 is provided with an enlarged opening 30 ofpredetermined diameter, the purpose for which will be describedsubsequently. The portion of the needle holder adjacent the proximal endis of relatively small diameter while the portion of the needle holderadjacent the distal end thereof is of larger diameter, both portionspreferably tapering slightly towards the proximal end, the overalllength of the needle holder being about twice the diameter of the largerportion. 'As best seen in FIG. 10, the outer edge of the distal end ofthe needle holder is provided with a generous radius. Slip-fitted overthe larger end of the needle holder 26 is a sleeve 36 also of asemirigid plastic material such as molded polyethylene or vinyl. Thesleeve 36 is provided with a shallow counterbore in its proximal enddefining a shoulder 38 against which the end of the needle holder 30engages. A slight flat 39 (FIG. 2) is provided on the wall of thecounterbore to assure a snug fit of the needle holder 26 within thecounterbore. The proximal end of the sleeve 36 is provided with anoutwardly protruding flange 40 and the opposite end of the sleeve ispreferably beveled on its inner surface as indicated at 41.

Bonded to the outer surface of the sleeve 36 by heat fusing or suitableadhesive is an elongate sac 42 of poly ethylene or vinyl or othersuitable transparent plastic material which is relatively permeable toethylene oxide or other like sterilizing medium. An adhesive tape 43 maybe wrapped about the sac 42 to protect the bond and which tape may becolor coded to indicate the needle size or other information. Theopposite end of the sac 42 is provided with a closure seal 44.

Disposed Within the sac 42 and the needle 20 is a catheter 46 which maybe formed of polyethylene or vinyl plastic or other suitable material.In the initial condition of the assembled apparatus of the invention thecatheter 46 is positioned with one end thereof within the lumen of theneedle 20, the body of the catheter being loosely disposed within thesac 42. This end of the catheter is preferably tapered, as shown in FIG.3 at 47, and free of any sharp edges. Tapering is accomplished byinserting the end of the catheter into a heated conical die and rotatingthe die relative to the catheter whereupon the heat softened plasticwill conform to the die convergence and any rough edges will flow andround off because of the surface tension effect. Fixedly secured to theopposite end of the catheter is a tubular adapter member 50 of asemi-rigid plastic material such as molded polyethylene or vinyl.

Referring to FIGS. 4 and 5, the adapter member 50 includes a proximalportion 52 formed with an opening 54 of sufiicient diameter snugly toreceive the catheter 46. The intermediate portion 56 of the adaptermember is of slightly larger diameter and is formed with an opening 58of larger diameter than the opening 54, the end of the opening 53adjacent the opening 54 being provided with a conically tapered portion60. The end of the catheter 46 extends into the opening 58 and is flaredagainst the conical portion 60 so that the tube 46 cannot be pulledforwardly from the adapter member 50.

The distal end of the adapter member 50 is provided with an inwardlytapered opening 64 that defines a shoulder 66 with the wall defining theopening 58. Adapted to fit within the opening 64 is a plug 68 having abody 70 tapered complementarily to the opennig 64. The plug is formedwith a circumferential rib 72 which is adapted to engage with acircumferential groove 74 in the wall of the opening 64 before the plugis fully seated in the opening 64, the maximum diameter of the rib beingslightly less than the maximum diameter of the recess. The inner wall ofthe opening 64 is preferably provided with a protuberance 75 to urge therib on the opposite side of the plug into the groove 74. Theprotuberance is of narrow width so as to cause a space 76 to be providedbetween the walls of the plug and the opening as shown in FIGS. 4 and 6,so that a passage for air between the wall of the adapter and the plugbody is provided when the plug is in this position. The plug 70 is,however, adapted to be further inserted into the opening 64 as shown inFIG. 5, the elasticity of the Walls of the adapter member permittedinward movement of the plug. In the inward position of the plug the rib72 is in snug engagement with the wall of the recess 64 so as to providea circumferential seal between the plug and the adapter member 50 toprevent the escape of any fluid matter from the interior of the adaptermember.

Preferably a tubular guard 80 is provided over the needle 20, the guardhaving a hub 82 which is slip-fitted upon the end portion 24 of theneedle holder 26.

The proximal end of the guard 80 is reduced in diameter and the opening83 through such end is of a diameter slightly less than the diameter ofthe needle 20 to prevent the needle from protruding outwardly of thesleeve in the event any accidental movement should cause disengagementof the needle 20 from the needle holder 24. Also, the guard 80 isprovided with a plurality of inwardly projecting radial elements 84(FIG. 7) which are spaced from one another so as to provide a space fora gas passage therebetween, but which meet at the center of the guard soas to provide a stop and prevent any accidental extension of thecatheter 46 outwardly of the guard.

Enclosing all of the elements described heretofore is an outer envelopeor sac 90 which also is preferably formed of a transparent, gaspermeable, pliant, plastic material such as polyethylene or vinyl. Theend of the sac 90 adjacent the needle guard 80 is provided with acomplete transverse seal. The opposite end is likewise provided with atransverse seal, but which is interrupted by a multi-strand, loose,cotton wick 92, the purpose of which will be described. The thickness ofboth the sac 42 and sac 90 is exaggerated for ease of illustration, theactual thickness of both being only about 0.005" to 0.010.

In assembling the apparatus shown in FIG. 1 the catheter 46 is insertedthrough the opening 54 and partially into the opening 58 of the adaptermember 50 and the end of the catheter tube expanded by pressing a heatedexpanding tool against the end of the tube, to cause the same to spreadoutwardly against the conical wall as shown in FIG. 4. Thereafter theplug 68 is positioned in the adapter with the rib 72 within the recess74. The catheter and adapter member 50 are then inserted into the sac 42which has previously been secured in position upon the sleeve 36. Theneedle 20 and needle holder 26 are then assembled and the needle holderinserted into the sleeve 36 at the same time manipulating the proximalend of the catheter 46 so that it is guided into the lumen of the needle20. The needle guard is then positioned over the needle and thisassembly positioned Within the envelope which is then sealed. Thisentire apparatus can then be placed within an autoclave forsterilization.

In the sterilizing procedure the autoclave is evacuated to about 28 mm.of mercury and the temperature raised to about F. with the relativehumidity maintained at about 40 percent. This stimulates anerobicbacteria and makes them vulnerable to ethylene oxide. After apredetermined period of time ethylene oxide (mixed with 80 percentcarbon dioxide) is introduced into the autoclave and the pressure raisedto about 33 p.s.i. The ethylene oxide will, of course, penetrate the sac90 through the wall thereof, but the wick 92 also facilitates passage ofthe gas into the sac. Likewise, some ethylene oxide will pass throughthe Wall of the sac 42, but the passage through the end of the needleguard will permit gas to flow rapidly into the interior of the needleand catheter which are of course substantially evacuated during theprevious step. After a predetermined period of time the pressure in theautoclave is reduced to atmospheric pressure. It is during the initialevacuation and final pressure reduction that the wick 92 plays a mostimportant function in providing a passage for the relatively rapidescape of gas from the sac 90. Unless the gas is bled from the sac at arelatively rapid rate so as to minimize the pressure differential as theautoclave pressure drops, the sac 90 is likely to rupture. The diffusionrate through the envelope wall is so slow as to require an inordinateylong .and uneconomic period to bleed gas in this manner at a safe rate.The wick 92, on the other hand, permits the autoclave pressure to bedropped rapidly.

When the apparatus is to be used the envelope 90 is opened as by cuttingoff one end and stripped off the enclosed apparatus. The needle guard 80is next removed from the needle 20 and a venipuncture in a patients armmade by forcing the needle 20 through the arm of the patient and into avein 91 in the customary manner and is indicated in FIG. 8. Of course,the usual customary precautions are taken to sterilize the area of thepatients arm prior to thrusting the needle therethrough. The sleeve 36is then grasped with one hand and the catheter 46 grasped with the otherhand through the sac 42 and pushed through the needle 20 into the vein91 of the patient. The catheter can be pushed any desired distance intothe vein. The tapered and rounded end 47 of the catheter minimizes thepossibility of trauma of the wall of the vein as is likely to occur withthe sharp and jagged edges remaining after the catheter is severed by aknife or other instrument from a longer length of tubing. When thecatheter 46 is properly positioned, a sterile pledget is placed over thepuncture in the patients arm and with digital pressure applied to thearm above the position of the catheter within the vein to hold it inplace, the needle 20 is withdrawn from the vein by grasping the sleeve36 and applying withdrawal pressure. The catheter is then secured inplace on the arm with adhesive tape 94 immediately adjacent the point ofinsertion, see FIG. 9. Thereafter the needle holder 24 is grasped in onehand and the sleeve 30 in the other, and the sleeve rotated lengthwise,as indicated by the arrow in FIG. 10, so as to remove the sleeve fromthe needle holder 26. As will 75 be apparent, the fact that the diameterof the needle holder is no greater than the depth of penetration of theneedle holder into the sleeve 36 facilitates the removal of the sleeveas does the provision of the gently rounded edge on the distal end ofthe needle holder. Of course, it is necessary the respective elements beof semirigid material to permit deflection to effect removal in thismanner. Removal of the sleeve 36 from the needle holder 26 in thismanner also prevents any accidental withdrawal of the needle from theholder as might occur if movement purely in the axial direction wereattempted. Furthermore, it the needle should be moved longitudinally ofthe catheter at this point, there is a possibility that the sharp edgeof the needle would cut or scarify the surface of the catheter. Afterremoval of the sleeve 36 from the needle holder the sleeve and sac 42can be discarded. The bevel 41 on the distal end of the sleeve 36minimizes any possibility of the sleeve catching upon the adapter member50 as the sleeve is drawn over the adapter member.

Thereafter the needle is firmly grasped and the needle holder 26 movedaxially relative to the needle so as to remove the needle holder fromthe needle. The needle can then be immobilized on the patients arm bysecuring the needle in place with a strip 95 of adhesive tape, asindicated at 98 in FIG. 9. Preferably a piece of tape 99 is positionedon the patients arm beneath the point of the needle so as to prevent anypossibility of injury to the patient from the needle. If desired, apiece of tape can be wrapped about the needle point and the catheter toprevent any movement of the catheter relative to the needle and thusfurther assure against cutting of the catheter. A strip of tape 100 isalso positioned over the catheter immediately above the needle so thatthe catheter and needle are held in immobile position upon the patientsarm. The needle holder 24 can be then slipped up the catheter andengaged on the proximal end 52 of the adapter member 50.

In the insertion of the needle 20 and the catheter 46 into the patientsvein the pressure of the blood within the vein will force the blood intothe needle and up the catheter 46. The loose engagement of the plug 68is important in this regard since it permits the escape of air from thecatheter so that blood may completely fill the catheter and the cavitywithin the adapter mem- 'ber 50. When all of the air has been forced outof the catheter 46 and adapter member 50 the plug 68 can be movedinwardly to the position shown in FIG. 5 to seal the adapter and preventfurther escape of blood. It may be necessary to do this before steps tosecure the needle in place on the arm are completed.

Finally, the plug 68 may be removed from the adapter and a fitting 102of an infusion set inserted into the adapter opening 64 so that thetransfusion or injection of other fluid into the patient may commence.Filling of the catheter 46 and adapter 50 with blood is important ofcourse to prevent any possibility of air embolism.

It will be apparent that the sac 42 protects the catheter 46 and adaptermember 50 from contamination during insertion of the needle andmanipulation of the catheter to insert it into a vein. The guard 80protects the needle 20, of course, until the guard is removed. Thus,with reasonable precautions the needle 20 may be inserted and cathetermade ready for infusion without the necessity of the operator scrubbingor using sterile gloves since there is no need for the operator to touchany part that must remain sterile.

The fact that the needle 20 is of uniform outer diameter throughout itslength is important in that it permits the needle to lie flatly alongthe patients arm, thus to minimize any possibility of penetration of theneedle into the arm, as may result from movement by the patient.Furthermore, the needle may be maintained in axially parallel relationwith the catheter so that accidental cutting of the catheter is notlikely to occur.

The catheter 46 may be left in place in the patients vein betweentransfusions or infusions of fluid. When introductionof fluid in aparticular sequence is completed, the infusion set can be disconnectedfrom the adapter 50 and the plug 68, or another similar sterile plug,may be reinserted in place and pushed into sealing position as shown inFIG. 5 so as to prevent any loss of blood or contamination of theinterior of the catheter between infusions.

Having illustrated and described a preferred embodiment of the inventionit should be apparent to those skilled in the art that the inventionpermits of modification in arrangement and detail. I claim as myinvention all such modifications as come within the true spirit andscope of the appended claims.

What is claimed is:

1. Apparatus for use in intravenous introduction of a fluid comprising,

an elongate hollow needle of uniform inner and outer diameter throughoutits length,

one end of said needle being formed to provide a sharpened edge formaking a venipuncture,

a tubular needle holder removably mounted upon the opposite end of saidneedle,

a sleeve fitted over said needle holder,

a pliable sac secured at one end to the outer surface of said sleeve andextending rearwardly therefrom, the opposite end of said sac beingsealed,

and a flexible catheter positioned within said sac with one end withinsaid needle and extendable outwardly of said one needle end bymanipulation through said sac, the uniform outer diameter of the saidneedle permitting the same to be positioned flatly against a patientsbody after withdrawal of the needle from the venipuncture and removal ofsaid needle holder from said needle.

2. Apparatus for use in intravenous introduction of a fluid comprising,

an elongate hollow needle of uniform inner and outer diameter throughoutits length,

one end of said needle being formed to provide a sharpened edge formaking a venipuncture,

a tubular needle holder removably mounted upon the opposite end of saidneedle,

said needle holder having a counterbore in one end thereof snuglyreceiving said needle and defining a shoulder against which said needleis seated,

a sleeve having a counter bore in one end slidably receiving said needleholder,

a pliable sac fixedly secured at one end to the outer surface of saidsleeve and extending rearwardly therefrom, the opposite end of said sacbeing sealed,

and a flexible catheter positioned within said sac with one end withinsaid needle and extendable outwardly of said one needle end bymanipulation through said sac, the uniform outer diameter of the saidneedle permitting the same'to be positioned flatly against a patientsbody after withdrawal of the needle from the venipuncture and removal ofsaid needle holder from said needle.

3. Apparatus for use in intravenous introduction of a fluid comprising,

an elongate hollow needle of uniform inner and outer diameter throughoutits length,

one end of said needle being formed to provide a sharpened edge formaking a venipuncture,

a tubular needle holder having a proximal and a distal end removablymounted upon the opposite end of said needle said needle holder having acounterbore in said proximal end snugly receiving said needle anddefining a shoulder against which said needle is seated,

said needle holder including a first portion adjacent said proximal endof relatively small external diameter and a second portion adjacent thedistal end of relatively larger diameter,

a sleeve having a proximal and a distal end and a counter bore in saidproximal end'slidably receiving said distal end of said needle holder,

said sleeve counter bore defining a shoulder spaced from said sleeveproximal end by a distance less than the diameter of said needle holderdistal end, whereby said needle holder may be removed from said sleeveby rotating the same relative to one another about an axis transverse tothe longitudinal axes of said holder and said sleeve.

a pliable sac fixedly secured at one end to the outer surface of saidsleeve and extending rearwardly of the distal end thereof, the oppositeend of said sac being sealed,

and a flexible catheter positioned within said sac with one end withinsaid needle and extendable outwardly of said one needle end bymanipulation through said sac.

4. Apparatus for use in intravenous introduction of a fluid comprising,

an elongate hollow needle of uniform inner and outer diameter throughoutits length,

one end of said needle being formed to provide a sharpened edge formaking a venipuncture,

a tubular needle holder of semi-rigid material and having a proximal anda distal end removably mounted upon the opposite end of said needle,

said needle holder having a counter bore in said proximal end thereofsnugly receiving said needle and defining a shoulder against which saidneedle is seated, the distal end of said needle holder having an openingof predetermined larger diameter,

said needle holder including a first portion adjacent said proximal endof relatively small external diameter and a second portion adjacent thedistal end of relatively larger diameter, the overall length of saidneedle holder being substantially twice said larger diameter,

a sleeve of semi-rigid material having a proximal and a distal end andhaving a counter bore in said proximal end slidably receiving saiddistal end of said needle holder in a slip fit,

said sleeve counter bore defining a shoulder spaced from said sleeveproximal end by a distance less than the diameter of said needle holderdistal end, whereby said needle holder may be removed from said sleeveby rotating the same relative to one another about an axis transverse tothe longitudinal axes of said holder and said sleeve.

a pliable sac bonded at one end to the outer surface of said sleeve andextending rearwardly of the distal end thereof, the opposite end of saidsac being sealed,

a catheter of flexible plastic positioned within said sac with one endwithin said needle and extendable outwardly of said one needle end bymanipulation through said sac,

a said catheter one end being conically tapered to facilitate entry ofthe same into a vein,

a tubular adapter member of a semi-rigid material fixedly secured at oneend thereof to the opposite end of said catheter,

said one end of said adapter member being of an outer diameter snugly tofit within the opening in said needle holder distal end,

the opening in the opposite end of said adapter member being inwardlytapered and having an annular recess in the wall thereof adjacent saidopposite end,

a plug of complementary taper inserted in said adapter opening from saidopposite end,

said plug having an annular rib adapted to fit within said annularrecess,

the maximum diameter of said rib being slightly less than the maximumdiameter of said recess and said rib being positioned in said plug sothat said rib engages in said recess before said plug is fully seated insaid opening whereby air may escape from said catheter through theclearance space between said plug and said adapter member,

and an elongate tubular guard enclosing said needle and detachablysecured to said needle holder.

References Cited by the Examiner UNITED STATES PATENTS 2,421,313 5/47Brandon 215-47 2,731,012 1/56 Henderson 128-215 2,799,272 7/57 Peach128-221 2,915,063 12/59 Cutter 1282l4 2,947,415 8/60 Garth.

3,017,884 1/62 Doherty et a1 128-214 3,030,953 4/62 Koehn 128221 X3,055,361 9/62 Ballard 128214 3,084,793 4/63 Pitman 206-632 3,094,1226/63 Gauthier et a1. 128--221 3,123,211 3/64 Sorenson 20663.2

RICHARD A. GAUDET, Primary Examiner.

JORDAN FRANKLIN, Examiner.

1. APPARATUS FOR USE IN INTRAVENOUS INTRODUCTION OF A FLUID COMPRISING,AN ELONGATE HOLLOW NEEDLE OF UNIFORM INNER AND OUTER DIAMETER THROUGHOUTITS LENGTH, ONE END OF SAID NEEDLE BEING FORMED TO PROVIDE A SHARPENEDEDGE FOR MAKING A VENIPUNCTURE, A TUBULAR NEEDLE HOLDER REMOVABLYMOUNTED UPON THE OPPOSITE END OF SAID NEEDLE, A SLEEVE FITTED OVER SAIDNEEDLE HOLDER, A PLIABLE SAC SECURED AT ONE END TO THE OUTER SURFACE OFSAID SLEEVE AND EXTENDING REARWARDLY THEREFROM, THE OPPOSITE END OF SAIDSAC BEING SEALED, AND A FLEXIBLE CATHETER POSITIONED WITHIN SAID SACWITH ONE END WITHIN SAID NEEDLE AND EXTENDABLE OUT-